Introducing OpenCDISC Enterprise 3.0

October 27, 2015


Pinnacle 21 is proud to announce the launch of OpenCDISC Enterprise 3.0, which will be available November 2, 2015. This enhanced, comprehensive, web-based application makes it easier than ever to manage standards compliance over the entire study life-cycle.

Now, instead of validating data right before regulatory submission (and unearthing a world of problems), you can manage it from the beginning: controlling your process, mitigating your risk, and reducing your time to market.

“Continuous Compliance” is Pinnacle 21’s proprietary approach for managing and ensuring consistent data from the moment you design the protocol all the way through to FDA and PMDA submission — and OpenCDISC Enterprise 3.0 is the tool that drives it. The result is an intelligent process that:

  • Eliminates risk
  • Saves time and money
  • Achieves faster FDA approval

Seven years ago, Max Kanevsky and the team introduced Validator: a progressive open-source tool for ensuring SDTM and ADaM compliance. Today, we’re edging the life-sciences industry forward again: delivering an evolved technology that sets the groundwork for a more-intelligent, more-efficient, more-confident clinical development process.

Did you know … ?

A version of OpenCDISC Enterprise, known as “DataFit”, is used by the FDA to screen incoming submissions.

OpenCDISC Enterprise 3.0, highlighted features:

  • Define.xml Designer
  • Issue Management
  • Issue Filters

Managing compliance should start the moment you design your first study. OpenCDISC Enterprise 3.0 enables you to do just that. Create a study data specification to define what your study is going to look like. Then, as you begin to gather data, leverage the software’s Issue Management tools to identify what issues you have and what’s changed since the last time you received the data, so you can track changes and progress over time (instead of having to start from scratch each time you run the data).

The intuitive platform makes it easy to manage the process from beginning to end. As data issues arise, you can take actions to address them, assign tasks to others, add comments, and more. Plus, you can define Issue Filters for different use cases. So, rather than dealing with every irrelevant issue, you can target only the specific subsets that concern you (e.g., Study Startup, Ongoing, Pre-Hard-Lock, FDA or PMDA submission) — simplifying the overall process.

Plus, our new API makes it simple to integrate OpenCDISC Enterprise 3.0 with other systems — e.g., metadata repository, data warehouse, single sign-on, etc. — so you can easily automate validation, enabling a truly end-to-end process.

With OpenCDISC Enterprise 3.0, you can:

  • Create your own standards
  • Upload your own terminology
  • Drive “Continuous Compliance” throughout your process

If you have any questions about OpenCDISC Enterprise 3.0 in advance of the launch, please email us.


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